This is a summary of the European public assessment report (EPAR) for Paglitaz. It explains how the
Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recomm ndations on the conditions of use for Paglitaz.
Paglitaz is a ‘generic medicine’. This means that Paglitaz is similar to a ‘reference medicine’ already
authorised in the European Union (EU) called Actos. For more information on generic medicines, see
What is PaglitazMedicinalused for?
Paglitaz is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight. It is us d in addition to diet and exercise.
- Pioglitazone actavis - pioglitazone hydrochloride
- Pioglitazone krka - pioglitazone hydrochloride
- Pioglitazone teva - pioglitazone hydrochloride
- Glubrava - metformin hydrochloride / pioglitazone hydrochloride
- Actos - pioglitazone hydrochloride
- Sepioglin - pioglitazone hydrochloride
Prescription drugs listed. Substance: "Pioglitazone hydrochloride"
Paglitaz is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Paglitaz can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy’).
Paglitaz can also be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy’).
© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.
How does Paglitaz work?
Paglitaz can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
The medicine can only be obtained with a prescription.
How is Paglitaz used?
- Zyllt - Krka, d.d., Novo mesto
- Ecansya (capecitabine krka) - Krka, d.d., Novo mesto
- Ifirmacombi - Krka, d.d., Novo mesto
- Clopidogrel krka d.d. (zopya) - Krka, d.d., Novo mesto
- Nimvastid - Krka, d.d., Novo mesto
- Oprymea - Krka, d.d., Novo mesto
Prescription drugs listed. Manufacturer: "Krka, d.d., Novo mesto"
The recommended starting dose of Paglitaz is 15 or 30 mg once a day. This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed. Paglitaz should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease). The tablets should be swallowed with water.
Treatment with Paglitaz should be reviewed after three to six months, and discontinued in patients who
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Paglitaz, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.
What are the benefits and risks of Paglitaz?
Why has Paglitaz been approved?
Because Paglitaz is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are takenMedicinalas being the s me as the reference medicine’s.
The CHMP conclu that, in accordance with EU requirements, Paglitaz has been shown to have
comparable quality and to be bioequivalent to Actos. Therefore, the CHMP’s view was that, as for Actos, the benefit outweighs the identified risk. The Committee recommended that Paglitaz be given marketing authorisation.
Other information about Paglitaz
The European Commission granted a marketing authorisation valid throughout the European Union for Paglitaz on 21 March 2012.
The full EPAR for Paglitaz can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Paglitaz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The full EPAR for the reference medicine can also be found on the Agency’s website.
This summary was last updated in